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The purpose of this study is to determine whether the dual therapy of the amino acid L-CARNITINE and magnesium have an effect on reducing the liver fat content in patients with non alcoholic fatty liver disease (NAFLD).
The purpose of this study is to determine whether the dual therapy of the amino acid L-CARNITINE and magnesium have an effect on reducing the liver fat content in patients with non alcoholic fatty liver disease.
the study is an interventional one in which 60 patients who by definition have non alcoholic fatty licer disease (NAFLD) are divided randomly (double blind) into 2 groups: group 1: "study group". receive a product (flavoured water) which contains L-CARNITINE an magnesium. group 2: control. receive placebo. regular water. Length of trial - 12 weeks. The patients will be followed on a weekly base and variuos parameters will be compared (weight, lipid profile, insulin resistance etc.).
"fibrotest" will be used at the beginning of the trial and at the end (week 12) comparing the fat content before and after the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| water | Placebo Comparator | just water | |
| L-CARNITINE AND MAGNESIUM ("slim water" product) | Experimental | The experimental arm will receive a product "slim water", which contains 150 mg magnesium lactate and 2000 mg L-carnitine. The purpose is to follow the patients and examine several metabolic parameters over time (liver function test, lipid profile, liver fat content, etc.) and by that to show and prove the positive effect of the experimental treatment over placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "slim water" | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| effect of LCARNITINE and magnesium treatment on the liver fat content | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| effect of L-CARNITINE and magnesium treatment on the metabolic panel | hepatic enzyme profile, lipid profile, weight, inflammatory markers, insulin resistance | 12 weeks |
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Inclusion Criteria:
age>18, <80 y evidence to non alcoholic fatty liver disease
Exclusion Criteria:
age<18, >80 y pregnancy renal failure congestive heart failure active malignancy liver disease - etiology other than non alcoholic fatty liver disease (NAFLD). hypothyroidism/cushing total prenteral nutrition (TPN) in the last 6 month
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DAN FELDMAN, MD | Contact | 0522794025 | danifel100@gmail.com | |
| YONA KITAY, MD | Contact | 09-7471560 | yonaki@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| DAN FELDMAN, MD | Meir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Hospital | Kfar Saba | Israel |
|
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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